Air Uterine Displacer-Aud 120
FDA 510(k) K833022 · Scientific Sales Intl., Inc.
510(k) numberK833022
Submission
- Device name
- Air Uterine Displacer-Aud 120
- Applicant
- Scientific Sales Intl., Inc.
Walker, MI, US - Received
- September 6, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCX – Support, Patient Position
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6820
- Specialty
- Anesthesiology
Other 510(k)s with product code CCX
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|---|---|---|---|
| K943837 | Chin UpCCX · Traditional | Edward Carden | 10/14/1994SE |
| K932305 | Vila-Cooke(Tm) Anesthesia PillowCCX · Traditional | Sharn, Inc. | 10/05/1993SE |
| K934235 | Sniff Position PillowCCX · Traditional | American Medical Development, Inc. | 10/01/1993SE |
| K861915 | Surgical Head SupportCCX · Traditional | Treace Medical, Inc. | 05/30/1986SE |
| K821838 | Vari-Support Low Back Posture PillowCCX · Traditional | Body Therapeutics, Inc. | 07/20/1982SE |
| K810035 | Prenatal Support PillowCCX · Traditional | Supportech, Inc. | 01/23/1981SE |
| K801330 | Anspach Leg SupportCCX · Traditional | The Anspach Effort, Inc. | 06/26/1980SE |
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| K953677 | Lighted Flexguide (Modification)BSR · Traditional | 08/25/1995SE |
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| K860996 | Sanassay Ic TestDAK · Traditional | 03/30/1987SE |
| K862087 | Santest 1APLKL · Traditional | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | 04/25/1986SE |
| K853285 | Mywasher 5LIB · Traditional | 10/04/1985SE |
| K853284 | Myreader 7JJQ · Traditional | 10/04/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | 09/12/1985SE |
| K853379 | Plate IncubatorJTQ · Traditional | 09/03/1985SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | 10/23/1980SE |
Questions and answers
When was Air Uterine Displacer-Aud 120 cleared by the FDA?
Air Uterine Displacer-Aud 120 (K833022) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 38 days after the submission was received.
What is the product code of K833022?
The FDA product code is CCX – Support, Patient Position, a Class I (low risk) device regulated under 21 CFR 868.6820.